Using Herombopag to treat low platelet counts in liver disease patients needing surgery
The Efficacy and Safety of Herombopag in Treating Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Surgery - A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study
This study is testing if a medication called Herombopag can safely raise low platelet counts in patients with liver disease who need surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 101 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. Industry-sponsored |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06507436 on ClinicalTrials.gov |
What this trial studies
This clinical trial consists of two parts: Part A focuses on determining the appropriate dosage of Herombopag for patients with chronic liver disease-related thrombocytopenia who are scheduled for elective surgery. Part B is a multicenter, randomized, double-blind, placebo-controlled Phase III study that aims to assess the efficacy and safety of Herombopag compared to a placebo in the same patient population. The study will involve administering either Herombopag tablets or placebo tablets to evaluate their effects on platelet counts prior to surgery.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with chronic liver disease and a platelet count below 50×10^9/L who are scheduled for elective invasive procedures.
Not a fit: Patients with a history of thrombosis or other conditions causing thrombocytopenia may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve platelet counts in patients with chronic liver disease, facilitating safer elective surgeries.
How similar studies have performed: While this approach is being evaluated in this Phase III trial, similar studies have shown promise in treating thrombocytopenia, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Males or females aged 18 years or older withc a Child-Pugh score of Class A or Class B; 2. Platelet count less than 50×10\^9/L on baseline; 3. Elective invasive procedures or surgeries that are planned. Exclusion Criteria: 1. Any history of arterial or venous thrombosis, including partial or complete thrombosis; 2. Evidence of thrombosis (partial or complete) in the main portal vein, portal vein branches, or any part of the splenic mesenteric system at Screening; 3. Portal vein blood flow velocity rate \<10 centimeters/second at Screening; 4. There are other diseases that may cause thrombocytopenia.
Where this trial is running
Shanghai, Shanghai Municipality
- Zhongshan Hospital, affiliated with Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Ting Zhang
- Email: ting.zhang.tz89@hengrui.com
- Phone: +86 0518-82342973
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.